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Clovis Oncology Inc (CLVS.OQ)

CLVS.OQ on NASDAQ Stock Exchange Global Select Market

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12 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Clovis Oncology reports Q3 adjusted shr loss of $1.24
Wednesday, 1 Nov 2017 

Nov 1 (Reuters) - Clovis Oncology Inc -:CLOVIS ONCOLOGY ANNOUNCES THIRD QUARTER 2017 OPERATING RESULTS.Q3 ADJUSTED LOSS PER SHARE $1.24 EXCLUDING ITEMS.Q3 LOSS PER SHARE $1.24.Q3 EARNINGS PER SHARE VIEW $-1.22 -- THOMSON REUTERS I/B/E/S.  Full Article

Clovis oncology says entered into a manufacturing services agreement - sec filing
Tuesday, 4 Oct 2016 

Clovis Oncology Inc : Says Clovis Oncology and Lonza Ltd entered into a manufacturing services agreement - SEC filing .Deal provides Lonza will be non-exclusive manufacturer of Rucaparib Api during term of deal , which expires on December 31, 2025.  Full Article

Clovis Oncology announces Rucaparib data presentations at ESMO 2016 Congress
Wednesday, 28 Sep 2016 

Clovis Oncology Inc : Clovis Oncology announces Rucaparib data presentations at ESMO 2016 Congress . European Marketing Authorization Application (MAA) planned in Q4 2016 . ESMO will take place october 7-11, 2016 in Copenhagen, Denmark . Prescription Drug User Fee Act (PDUFA) date is February 23, 2017 . U.S. FDA accepted accelerated approval application for review and granted priority review status for Rucaparib .Data from ARIEL3 are expected in Q4 2017, which is expected to be followed by submission of a supplemental NDA.  Full Article

Clovis enters into first amendment to license agreement between Clovis and pfizer
Tuesday, 30 Aug 2016 

Clovis Oncology Inc : Entered into first amendment to license agreement between Clovis and Pfizer, Inc. . First amendment amends existing license agreement, between Clovis and Pfizer, dated June 2, 2011 . Amendment amends license agreement to permit co to defer milestone payments payable upon fda approval of an NDA for 1(st)indication in US .Amendment amends existing license agreement to permit co to defer milestone payments payable on EMA approval of MAA for 1(st)indication in EU.  Full Article

Clovis Oncology says FDA accepts co's new drug application for rucaparib for priority review
Tuesday, 23 Aug 2016 

Clovis Oncology Inc : FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer .FDA assigns PDUFA date of February 23, 2017.  Full Article

Clovis Oncology Q2 adjusted loss per share $2.07 excluding items
Monday, 8 Aug 2016 

Clovis Oncology Inc : Clovis oncology announces q2 2016 operating results and corporate update . Q2 adjusted loss per share $2.07 excluding items . Q2 earnings per share view $-2.10 -- Thomson Reuters I/B/E/S .Q2 loss per share $3.37.  Full Article

Clovis Oncology Inc files for mixed shelf of up to $200 mln
Friday, 10 Jun 2016 

Clovis Oncology Inc :Clovis Oncology Inc files for mixed shelf of up to $200 million.  Full Article

Clovis Oncology Announces Rociletinib New Drug Application meeting schedule
Friday, 12 Feb 2016 

Clovis Oncology Inc:Says U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee April 12.ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.  Full Article

BRIEF-Clovis Announces Priority Review Designation For Rucaparib Supplemental NDA

* CLOVIS ANNOUNCES PRIORITY REVIEW DESIGNATION FOR RUCAPARIB SUPPLEMENTAL NEW DRUG APPLICATION